D
Patient 1
THE EBIOSAFE CHOLESTEROL KIT IS LABELED AS "OUCHLESS" AND "PAINLESS" THIS IS A MISREPRESENTATION. THE LANCET THEY USE IS NOT OUCHLESS OR PAINLESS.
MAUDE MDR 378364
- MDR report key
- 378364
- Report number
- MW1024125
- Event key
- 0
- Event type
- 3
- Date received
- 2002-02-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TOTAL CHOLESTEROL TEST KIT | CHOLESTEROL TEST | BIOSAFE DIAGNOSTIC PRODUCTS, INC. | NFX | * | * | * | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2002-02-08 | 0 | 1. O |